Ankit Kansagra, Medical Oncologist and Associate Vice President of Oncology Integration, shared Shebli Atrash’s, Oncologist at Levine Cancer Institute, post on X, adding:
“Aspirin or a DOAC at lenalidomide (len) start? I make that call almost every day, and the randomized evidence under it is thinner than our confidence.
RithMM (Louzada and the London/Ottawa/Halifax group, Current Oncology) is a pilot RCT: rivaroxaban 10 mg vs aspirin (ASA) 81 mg daily for the first 6 months of len-dex based therapy. 55 patients, 27 vs 28, median age 74.
- 2 VTEs (one DVT, one PE) and 2 bleeds, all in the ASA arm. One was a GI bleed needing admission.
- Zero thrombotic or bleeding events on rivaroxaban.
- Attrition 25.5%, way above the 10% they planned for.
- Missed its 86-pt feasibility target, largely due to COVID.
Small numbers, and the authors are upfront that it isn’t powered for any of this. Also only 70.4% of the rivaroxaban arm completed 6-month follow-up vs 85.7% on aspirin (ASA), so ‘no bleeds’ on rivaroxaban is partly less time to have one.
Recently I posted the International Myeloma Foundation (IFM) recommendations, which now say DOAC for everyone on an IMiD and call aspirin insufficient. That’s a strong rec sitting mostly on cohorts and single-arm apixaban data. By the authors’ count this is the only RCT of ASA vs a DOAC in multiple myeloma. And it’s 55 patients.
The challenge is translational and pretty practical. A full trial needs 398 patients across 7 sites, and this pilot shows how hard even 55 was. Thromboprophylaxis trials rarely get industry money, so someone has to fund the unglamorous ones.
Thanks Shebli Atrash for flagging this one.
For my multiple myeloma colleagues: Are you routinely doing a DOAC over aspirin with len-based quads now, or still risk-scoring? This helps me a ton, I deal with insurance issues in approval for DOAC’s all the time!”
Quoting Shebli Atrash’s post:
“RithMM: 55 patients on len-dex randomized to aspirin vs rivaroxaban at 3 Canadian centers. 2 VTEs and 2 bleeds, all in aspirin arm. Pilot only; enrollment goals were missed due to COVID, full trial looks feasible. Worth answering for our patients.”
You can also read:
Luciano Costa: The “BALI” Strategy for Preventing Infections in Multiple Myeloma Patients
